MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-08 for OLYMPUS TELESCOPE A22002A manufactured by Olympus Winter & Ibe Gmbh.
[1695340]
The user facility reported that during a therapeutic transurethral resection of bladder tumor (turbt) procedure, the users experienced a complete loss of image. The user facility reported that when the first telescope was introduced to the pt, and when the user pressed the foot switch of the electrosurgical unit, the user observed a visual arcing, heard two "poofs", and reportedly smelt an electrical burn; however, the user did not specify the source. The user subsequently reported that they could no longer see anything through the telescope. The user withdraw the first telescope and used a second telescope. Upon insertion of the second telescope it blew out, the telescope was then withdrawn from the pt, and a third telescope was used and this time the users replaced the working element, bovie cord. Upon introduction of the third telescope to the pt, the third telescope blew out. The first three attempts were reportedly performed by a resident. Finally, the attending physician replaced all the equipment in the system except for the electrosurgical unit and the light source, and completed the procedure without any adverse impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
[8691268]
Olympus followed up with the user facility via telephone and in writing to obtain additional and clarifying information regarding the report, as there was conflicting information provided regarding the report; however, no further information was provided. The telescope referenced in this report was returned to olympus with the complaint of blurry image. The evaluation confirmed the users report of image difficulty due to broken lens inside the optical fiber system. In addition, the outer tube was found bent, which likely caused the image difficulty. The bent outer tube is attributed to physical damage due to mishandling. The concomitant devices were not returned to olympus for evaluation. If additional significant information will become available later, this report will be supplemented. This report is being submitted as a medical device report in an abundance of caution. Olympus america inc is filing mdrs (b)(4). Cross-referenced mfr. Report number 9610773-2010-00034, and 9610776-2010-00036 for the associated device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610773-2010-00035 |
| MDR Report Key | 1867410 |
| Report Source | 06 |
| Date Received | 2010-10-08 |
| Date of Report | 2010-09-09 |
| Date of Event | 2010-09-09 |
| Date Mfgr Received | 2010-09-09 |
| Date Added to Maude | 2010-11-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LAURA STORMS-TYLER |
| Manufacturer Street | 2400 RINGWOOD AVE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4848965688 |
| Manufacturer G1 | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 22045 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS TELESCOPE |
| Generic Name | TELESCOPE |
| Product Code | FBP |
| Date Received | 2010-10-08 |
| Returned To Mfg | 2010-09-17 |
| Model Number | A22002A |
| Lot Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-08 |